The essentials for BTK procedures: wires, balloons, what else

Transcription

1 A comprehensive approach to diabetic patient Tx The essentials for BTK procedures: wires, balloons, what else Dai-Do Do Clinical and Interventional Angiology Cardiovascular Department

2 Disclosure Speaker name: Dai-Do Do I have the following potential conflicts of interest to report: X Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

3 Vascular features of diabetic foot Acral gangrene Heavy calcification Distal angiopathy ABI = limited value! N. Diehm, S. Rohrer, I Baumgartner, H. Keo, D.D. Do, C. Kalka Vasa 2008;37(3):256-73

4 New Frontiers Extreme Dilatation More experiences New techniques/accesses New 0.014`` What else? Old = 0.035`` Low profile & OTW long balloon catheter CTO dedicated GW 0.014`` GW

5 New Approach - Pedal Loop

6 Tip Diameter = Guide Wires Tip Load & Penetration Power Tip Load = 4.0g Area of GW Tip r Tip Load / Area of GW Tip.004kg/(3.14* ) Penetration Power = 40 (Guide Wire Tip)

7 BTK - Tools Guide Wires polymer-coated, (Astato 30, V-18 Control, Connect ) WG, CTO- GW (Astato 20,..) Support Catheter: CXI (OD 2.6 French) CXC (Cook) TrailBlazer (Covidien) TOTAL across TM, Bard.

8 79 y-o diabetic male with CLI left leg

9 79 y-o diabetic male with CLI left leg TOTAL across TM

10 Crossing strategies - INTRALUMINAL Advantages It is the standard technique More experiences It seems more «biological» No re-entry problem Limits not always possible to stay intraluminal in long & calcified lesions Usually unsatisfactory results after Balloon PTA Dissected irregular lumen CTO devices:

11 Crossing strategies - SUBINTIMAL Advantages Less time comsuming, even in cases of flush occlusion Smoother lumen Probably less distal embolization Limits Long learning curve No controled re-entry Risk of collateral occlusion Risk of vessel perforation Re-entry Devices:

12 72 y-o diabetic male with CLI right leg

13 72 y-o diabetic male with CLI right leg

14 BTK Endo Tx Angiographic Restenosis Problem: High recurrent rates after POBA Restenosis rates up to 3 months

15 CLI Problem of Re-stenosis Clinically-driven need for secondary interventions after endovascular revascularization of tibial arteries in patients with critical limb ischemia Baumann F, et al. JEVT 2013;20: : 128 consecutive CLI patients undergoing infrapopliteal angioplasty Prospectively followed 2-year data: Mortality: 29.1% Limb salvage: 89.9%. TLR: 46.2%.

16 BTK Interventions Limitations Strategies to reduce restenosis: New technologies: DEB DES Cre8 TM BTK

17 Problem of Ballon-PTA : recoil! Occlusion POBA 3/40 Angio immediately post PTA: MLD: 2.34 Angio 12 min post PTA: MLD: 1.25

18 Problem Elastic Recoil in Tibial Art. Consecutive series of 30 CLI patients with de-novo tibial lesions, serial angiography 15 minutes post POBA Mean lesion length 83.8 mm Elastic recoil (MLD reduction >10%) 96.7% Loss of MLD due to elastic recoil 29.4% Bailout stenting in 33% Baumann F., Fust J, Engelberger R; Hügel U; Do DD, Willenberg T; Baumgartner I; Diehm N. J Endovasc Ther 2014 Feb;21(1):44-51

19 DES are worthwhile in BTK lesions Data from RCT trials 1-Year Patency Rates BMS or PTA DES 55, DES 54, DES 58,1 80,6 DES BMS BMS PTA P<0.05 all trials Yukon a) Destiny b) Achilles c) n=161 n=140 n=200 max. 4.5 cm max. 4.0 cm max cm a) Rastan A. b) Bosiers M. c) Scheinert D.

20 84 y-o w unhealing ulcers & rest pain Type II diabetic, hypertensive and active smoking

21 84 y-o w unhealing ulcers & rest pain SFA SFA

22 84 y-o w unhealing ulcers & rest pain Cre8 TM BTK A. popl Trunc tib.-fib

23 Cre8 TM BTK: distinctive features Abluminal Reservoir Technology Amphilimus Formulation: Sirolimus + organic acid BIS: Bio Inducer Surface

24 mm mm Cre8 for de novo lesions (max 2 in 2 different vessels) in native coronary arteries D. Carrié et al JACC, 2012, 59; Primary Endpoint: 6-month in-stent Late Lumen Loss Overall Population Cre8 (148 les,141 pts) Diabetic subgroup 0,5 0,4 0,3 TAXUS Liberté (145 les,135 pts) - 60% 0.34±0.40 P< % 0.43±0.41 P= Cre8 (42 les, 42 pts) 0,2 0.14± ±0.29 TAXUS Liberté (38 les, 33 pts) 0, In-stent LLL In-stent LLL The Late Lumen Loss in the diabetic subgroup is comparable to the Late Lumen Loss obtained in the overall population (never seen before!)

25 % of patients % of patients NEXT: 36-month clinical results 36-month cumulative MACE (Cardiac death, all MI, all TLR) Overall population Diabetic population Cre8 (144 pts) TAXUS Liberté (138 pts) p=0, ,2 Cre8 (44 pts) TAXUS Liberté (33 pts) p=0, , p=0, ,1 8,3 p=0,6227 p=1,0000 2,1 2,1 2,2 0,7-37% p=0,2464 Hierarchical MACE Cardiac death MI TLR 6,9 10,9 12/144 14/138 3/144 1/138 3/144 3/138 10/144 15/ % 9,1 p=1,0000 6,8 4,5 3, /44 7/33 0/44 0/33 2/44 1/33 3/44 7/33 Hierarchical MACE Cardiac death MI TLR Cre8 has shown that MACE and TLR in the diabetic subgroup are comparable to MACE and TLR obtained in the overall population!

26 Bioresorbable Scaffold - Peripheral

27 Limitation of DES - Lengths BTK Lesions Baumann F. et al. J Endovasc Ther. 2013;20(2): Lesions substantially longer than in DES trials!

28 History of a 96 y-old male with CLI DEB DES DEB

29 History of a 96 y-old male with CLI former DES DEB

30 Summary Access: - rather femoral antegrad, Heparin 7 500, Nitroglyerin - Pedal access a/o combined in some cases using 21 G needle. sheathless, or GW, hydrophlic, CTO GW BTK: - Low profile instrumentarium, rather long OTW balloon and long inflation time Revascularization: straight-line flow to the foot! (wound) Patency: Improvement using - DEB - adjunctive techniques and optional stenting (DES) if needed TASC. J Vasc Surg 2000; 31: 1-256; Söder et al. JVIR 2000; 11: Rosenfield, oral presentation ACC 2005; Bull PG et al. J Vasc Interv Radiol 1992; 3: 45-53; Brown et al.ccardiovasc Intervent Radiol 1992; 15: ; Bakal et al. AJR 1990; 154: 171-4

31 A comprehensive approach to diabetic patient Tx The essentials for BTK procedures: wires, balloons, what else Dai-Do Do Clinical and Interventional Angiology Cardiovascular Department